- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00828646
Safety Study of Multiple-dose of Gamma-secretase Inhibitor in Healthy Male Japanese and Healthy Elderly Japanese (JMAD)
January 6, 2011 updated by: Bristol-Myers Squibb
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 in Healthy Male Japanese Subjects and a Comparison to Healthy Elderly Japanese Subjects
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following 14-day multiple oral doses BMS-708163 in healthy young male Japanese and healthy elderly male and female Japanese subjects
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kanagawa
-
Yokohama, Kanagawa, Japan, 2320064
- Local Institution
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 19 to 25 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2
- Men, ages 20 to 45, and men and women [not of childbearing potential (i.e., who are postmenopausal or surgically sterile)], ages 65 or older. Women are considered surgically sterile only if they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy. Women are considered postmenopausal only if they have had amenorrhea for ≥12 consecutive months, or for women on hormone replacement therapy (HRT), if they have a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
Exclusion Criteria:
- WOCBP
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to administration of investigational product
- Sexually active fertile men not using effective birth control if their partners are WOCBP
- Any significant acute or chronic medical illness
- Any current or recent? medical history of gastrointestinal disease that may affect evaluation of study treatment
- History of recent major surgery or gastrointestinal surgery that may impact on evaluation or absorption of study drug
- History of blood donation or blood transfusion within 4 weeks prior to the study treatment
- Intolerance to oral medication or venous access
- QTc interval (Bazett's correction) >500 ms at screening
- Smoking more than 10 cigarettes per day
- Recent (within 6 months) drug or alcohol abuse as defined in DSM IV
- Any other sound medical, psychiatric and/or social reason as determined by the investigator
- Subjects ≥ 65 yr are allowed to have age-related minimum or mild abnormalities in vital sign (i.e. blood pressure) or laboratory tests (i.e. blood sugar, serum cholesterol, or serum triglyceride) as far as they are not deemed signs or consequences of illness or organ dysfunction and a subject of medical treatment
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Positive urine screen for drugs of abuse
- Positive blood screen for hepatitis C antibody, or HIV or hepatitis B antigen
- Indicators of abnormal renal function at baseline: any urine protein
- History of allergy to Gamma-Secretase Inhibitor or related compounds
- History of any significant drug allergy
- Prior exposure to BMS-708163
- Exposure to any investigational drug or placebo within 4 weeks of study drug administration
- Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
- Use of any other drugs, including over-the-counter medications and herbal preparations, within 2 weeks prior to study drug administration
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BMS-708163 - Panel 1
(Age 20-45 years)
|
Capsules, Oral, 50 mg, once daily, 14 days
Capsules, Oral, 100 mg/day, once daily, 14 days
Capsules, Oral, 75 or 100 mg/day, once daily, 14 days
Capsules, Oral, once daily, 14 days
|
Experimental: BMS-708163 - Panel 2
(Age 20-45 years)
|
Capsules, Oral, 50 mg, once daily, 14 days
Capsules, Oral, 100 mg/day, once daily, 14 days
Capsules, Oral, 75 or 100 mg/day, once daily, 14 days
Capsules, Oral, once daily, 14 days
|
Experimental: BMS-708163 - Panel 3
(age 65 or above)
|
Capsules, Oral, 50 mg, once daily, 14 days
Capsules, Oral, 100 mg/day, once daily, 14 days
Capsules, Oral, 75 or 100 mg/day, once daily, 14 days
Capsules, Oral, once daily, 14 days
|
Experimental: BMS-708163 - Panel 4
(age 65 or above)
|
Capsules, Oral, 50 mg, once daily, 14 days
Capsules, Oral, 100 mg/day, once daily, 14 days
Capsules, Oral, 75 or 100 mg/day, once daily, 14 days
Capsules, Oral, once daily, 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events
Time Frame: Within 30 days after the follow-up evaluation on Day 28
|
Within 30 days after the follow-up evaluation on Day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentration
Time Frame: Day 21
|
Day 21
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
January 23, 2009
First Submitted That Met QC Criteria
January 23, 2009
First Posted (Estimate)
January 26, 2009
Study Record Updates
Last Update Posted (Estimate)
January 7, 2011
Last Update Submitted That Met QC Criteria
January 6, 2011
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CN156-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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